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Posted On: 11/05/2023 5:14:41 PM
Post# of 148878
The FDA provided guidance documents on what should be on the BLA for sponsors and CROs to read.
The FDA also provided clear directives, that were conveyed REPEATEDLY on minutes and IRs on what should be completed for the rolling review and the fundamentals of a BLA submission.
Amarex mentioned on their website that they have submitted BLAs in the past and therefore Kazempour "should know what is on a BLA."
STRAYHORN agreed that there is no "naivette" in those regards.
STRAYHORN could tell that they (Cytodyn) had 100% reliance on Amarex. Cytodyn did not challenge or asked questions. STRAYHORN ASSumed Cytodyn saw the minutes, but IF they needed clarity on certain issues, they never reached out.
During the in-person meetings, Cytodyn was NOT involved and they were just in nthe Background. It was unusual to see sponsors just be in the backgeround, Cytodyn did not say anything.
YOU would have to know what to look for ...to say anything. SO MUCH for a mechanical engineer and SK....DON'T KNOW SHIT>...No wonder WE got bagged by AMAREX/NSF.
The FDA also provided clear directives, that were conveyed REPEATEDLY on minutes and IRs on what should be completed for the rolling review and the fundamentals of a BLA submission.
Amarex mentioned on their website that they have submitted BLAs in the past and therefore Kazempour "should know what is on a BLA."
STRAYHORN agreed that there is no "naivette" in those regards.
STRAYHORN could tell that they (Cytodyn) had 100% reliance on Amarex. Cytodyn did not challenge or asked questions. STRAYHORN ASSumed Cytodyn saw the minutes, but IF they needed clarity on certain issues, they never reached out.
During the in-person meetings, Cytodyn was NOT involved and they were just in nthe Background. It was unusual to see sponsors just be in the backgeround, Cytodyn did not say anything.
YOU would have to know what to look for ...to say anything. SO MUCH for a mechanical engineer and SK....DON'T KNOW SHIT>...No wonder WE got bagged by AMAREX/NSF.
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